NICHD Domestic & International Pediatric & Maternal HIV & Other High-Priority Infectious Diseases Clinical Studies Network (NICHD Network)

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Overview

The NICHD Network conducts trials related to preventing and treating HIV and its complications in newborns, infants, children, adolescents, and pregnant women. Since 1987, the Maternal and Pediatric Infectious Disease Branch has funded the NICHD Network, currently comprising 15 domestic sites in 11 states and territories and 14 international sites in Argentina, Brazil, Kenya, Tanzania, and Thailand, plus a Data Coordinating Center (DCC).

The NICHD Network was established to conduct a single clinical trial evaluating the use of intravenous immunoglobulin prophylaxis for bacterial infections in 376 children with HIV. Over time, the network has expanded with changes in the demographics of pediatric and maternal HIV. The number and type of clinical trial sites in the network have changed, as well as the types of studies being done.

In 1990, the NICHD Network began collaborating with the National Institute of Allergy and Infectious Diseases (NIAID)-funded Pediatric AIDS Clinical Trials Group to expand clinical trial availability at NICHD clinical trials sites. This collaboration made it possible to conduct clinical trials further evaluating primary antiretroviral therapeutic agents, other therapies targeted at opportunistic infections, and interventions to prevent perinatal HIV transmission. This NIAID-NICHD Network collaboration continues today with the NIAID-funded International Pediatric, Maternal, Adolescent AIDS Clinical Trials (IMPAACT) Network.

As the HIV epidemic has evolved, so has the research addressed by the NICHD Network. In populations of women and children, research gaps related to HIV-associated co-infections such as tuberculosis (TB), hepatitis, and malaria have emerged as HIV research has become increasingly global in nature. As a result, the NICHD Network and NIAID-funded IMPAACT Network broadened their focus to include TB, malaria, hepatitis, and investigation of vaccines to prevent HIV-related or other high-priority infectious diseases in children, adolescents, and pregnant women, in addition to treatment of HIV.

In addition to its work with the IMPAACT Network, the NICHD Network collaborates with several other networks to design and conduct HIV-related trials, including the following:

The NICHD Network relies on flexible contract mechanisms to initiate timely, high-priority initiatives in response to unanticipated research needs and to conduct planned studies with established protocols.

In addition to a DCC, the NICHD Network uses a centralized specimen repository to store coded biological specimens from its studies. This repository serves as a resource for network and external investigators who are interested in answering specific questions related to HIV/AIDS.

Topic Areas

Current and future areas of research focus include:

  • Interventions to reduce perinatal HIV transmission, with the goal to eliminate perinatal HIV transmission globally
  • Pharmacokinetics and safety of antiretroviral (ARV) drugs in pregnant or lactating women with HIV and their newborns
  • Safety and pharmacokinetics of drugs for the treatment of HIV in infants, children, and adolescents, including those with co-morbidities such as malnutrition, TB, and malaria
  • Prevention and treatment of HIV-associated infectious/non-infectious morbidity in infants, children, adolescents, and women (pregnant and non-pregnant) with HIV
  • Evaluation of vaccines and other biomedical modalities to prevent HIV and other high-priority infectious diseases
  • Diagnosis, prevention, and treatment of other high-priority infectious diseases, specifically those that affect infants, children, adolescents, and pregnant and nonpregnant women domestically and globally, including the safety and pharmacokinetics of drugs to treat these infections
  • Development and evaluation of strategies to find a cure (or virtual cure/remission) for HIV in infants
  • Pathogenesis of HIV in infants and children and how it differs from adults within the context of clinical trials
  • Development of strategies to prevent HIV acquisition in adolescents and pregnant or lactating women

The NICHD Network also supports training and infrastructure development at its domestic and international sites in resource-limited countries to allow future participation in pediatric and perinatal clinical trials conducted within the network.

Westat, Inc., is currently the DCC for the NICHD Network.

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